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A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01534052
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : April 27, 2018
Last Update Posted : October 4, 2018
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
A study to assess the safety of continued administration of MDV3100 in subjects with Prostate Cancer who have already undergone treatment with MDV3100 and showed benefit.

Condition or disease Intervention/treatment Phase
Castration-Resistant Prostate Cancer (CRPC) Drug: Enzalutamide Phase 2

Detailed Description:
This was a multi-center extension study in participants with prostate cancer who have completed MDV3100 treatment study to assess the long-term safety of continued administration of MDV3100, when judged by the investigator to be in the best interest of the participant. For the study duration, all participants with castration-resistant prostate cancer (CRPC) maintained androgen deprivation with a Luteinizing Hormone Releasing Hormone (LHRH) agonist/antagonist unless they underwent bilateral orchiectomy. Participants were discontinued from study drug when the continued administration of study drug was deemed to be not in the participants' best interest by the investigator based on clinical assessment. Throughout the study, safety and tolerability were assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Participants had a safety follow-up visit 30 days after their last dose of study drug. Participants that did not meet any of the discontinuation criteria were eligible to continue to receive treatment with enzalutamide in study 9785-CL-0123 [NCT02960022] upon approval and activation of the study at the participating institution. Participants who enrolled in study 9785-CL-0123 [NCT02960022] were not required to have a safety follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Extension Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
Actual Study Start Date : October 21, 2011
Actual Primary Completion Date : April 18, 2017
Actual Study Completion Date : April 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Enzalutamide
Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
Drug: Enzalutamide
Other Names:
  • MDV3100
  • ASP9785
  • Xtandi

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days ]
    An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has completed a prior study with MDV3100, can be enrolled in this extension study without any interruption in study drug
  • No new clinically significant abnormalities based upon physical examination, safety laboratory data, vital signs, ECG, and other clinical assessments noted from the last visit conducted during the subject's active MDV3100 study prior to initiation of this study
  • Male subjects and their female spouses/partners who are of childbearing potential must be using highly effective contraception1 consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 3 months after final study drug administration. Male subjects must not donate sperm starting at Screening and throughout the study period and for at least 3 months after final study drug administration. 1Highly effective contraception is defined as:

    • Established use of oral, injected or implanted hormonal methods of contraception.
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    • Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal form/gel/film/ cream/suppository
  • Subject agrees not to participate in another interventional study while on treatment

Exclusion Criteria:

Subject will be excluded from participation if any of the following apply:

  1. Subject has a history of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumours, brain metastases, or alcoholism.
  2. Subject has a history of loss of consciousness or transient ischemic attack within 12 months prior to Day 1 of the completed preceding study.
  3. Use of the following prohibited medication/therapies:

    • Concomitant medication that likely could cause clinically relevant drug-to-drug interactions with MDV3100.
    • Other (than MDV3100) androgen-receptor (AR) antagonists (bicalutamide, flutamide, nilutamide).
    • Investigational therapy other than MDV3100 or investigational procedures of any kind.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01534052

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United States, Colorado
Site US107
Aurora, Colorado, United States, 80045
United States, Illinois
Site US104
Chicago, Illinois, United States, 60637
United States, Pennsylvania
Site US105
Pittsburgh, Pennsylvania, United States, 15215
United States, Texas
Site US106
San Antonio, Texas, United States, 78253
Moldova, Republic of
Site MD37301
Chisinau, Moldova, Republic of
South Africa
Site ZA2701
George, South Africa, 6529
Site ZA2702
Port Elizabeth, South Africa, 6001
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
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Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  Study Documents (Full-Text)

Documents provided by Astellas Pharma Inc:
Study Protocol  [PDF] June 20, 2016
Statistical Analysis Plan  [PDF] April 8, 2015

Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT01534052    
Other Study ID Numbers: 9785-CL-0121
First Posted: February 16, 2012    Key Record Dates
Results First Posted: April 27, 2018
Last Update Posted: October 4, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc:
Prostate Cancer
Castration-Resistant Prostate Cancer (CRPC)
Androgen receptor signaling inhibitor
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases